Multicenter Analysis of Different Approaches in Segmentectomies in Early-stage Lung Cancer

Recruiting

• Conditions: Early Stage Lung Cancer (I and II); Non-Small Cell Lung Cancer

• Registration Number: NCT06737107
• Lead Sponsor: Scientific Institute San Raffaele

Brief Summary

The study is a retrospective, observational and multicentric study. The study describes robotic segmentectomies performed in four referred centers, with the aim to assess the perioperative compilications of robotic segmentectomies compared to video-assisted thoracoscopic surgery (VATS) and open approach.

Detailed Description

Minimally invasive techniques have been gradually replacing open approach in the treatment of lung cancer. Video-assisted thoracoscopic surgery (VATS) was the first procedure to be developed in the thoracic field and is the most widespread. It has been associated with decreased postoperative pain, shorter recovery, decreased inflammatory response and improved tolerance to chemotherapy.

What is limiting video-assisted thoracoscopic surgery (VATS) spread is the steep learning curve, difficulties and discomfort to operate, suboptimal view and rigid instrumentation. These problems have been partially overcome by the Robotic technique (RATS).

This study aims to compare the perioperative complications of robotic segmentectomies to VATS and open approaches.

In addition, The secondary aim of the study is to analyze the duration of surgery, mediastinal and hilar lymph nodes dissection, rate of conversion of robotic approach compared to VATS, overall survival and disease free survival in the three different approaches.

The study is retrospective, observational and multicentric. The four centers involved are: IRCCS San Raffaele Hospital, IRCCS European Institute of Oncology - IEO, IRCCS Humanitas Research Hospital - ICH and the department of General Thoracic Surgery, Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.

The population includes: all patients that underwent segmentectomies from the 1st January 2010 to the 31st of December 2023 treated with robotic segmentectomy and VATS or open segmentectomy, reaching a total of 472 cases of which 50 from our hospital.

Study Timeline

• Study Start: 2024-11-26
• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-12-05
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 472

Inclusion Criteria

• Pre or post-operative diagnosis of NSCLC surgically treated with pulmonary segmentectomy from 1st January 2010 to the 31st to December 2023.
• Age > then 18 years at the moment of surgery

Exclusion Criteria

• Age < then 18 years at the moment of surgery
• diagnosis other than NSCLC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The perioperative complications of robotic approach	from the surgery at 30-90 days after	The investigators will measure the perioperative complications of robotic lung resection in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC).; Complications will be categorized according to the Clavien-Dindo scale.
The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach	30-90 days after surgery	The investigators will measure the perioperative complications of video-assisted thoracoscopic surgery (VATS) appraoch in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC).; Complications will be categorized according to the Clavien-Dindo scale.
The perioperative complications of the open approach	30-90 days after surgery	The investigators will measure the perioperative complications of open approach in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC). Complications will be categorized according to the Clavien-Dindo scale.

Secondary Outcome Measures

Name	Time	Method
Duration of surgery	up to 1 month	Duration of the surgery based on the approach measured in minutes
Quality of lymphadenectomy	up to 1 month	Number of lymphonodes station resected
Conversion rate	up to 1 month	Number of surgery procedures converted
Survival analysis	up to 5 years	Presence or absence of local and distant relapse

Trial Locations

Locations (4)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milan, Italy

Scientific Institute Ospedale San Raffaele; 🇮🇹 Milan, Italy

Istituto Europeo di Oncologia; 🇮🇹 Milan, Italy

Policlinico Universitario Agostino Gemelli; 🇮🇹 Rome, Italy